Phase
Condition
Ovarian Cancer
Ovarian Cysts
Vaginal Cancer
Treatment
Cyclophosphamide
iC9-CAR.B7-H3 T cells
Fludarabine
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Unless otherwise noted, subjects must meet all of the following criteria toparticipate in all phases of the study:
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to,understood by and signed by the subject.
Age ≥ 18 years at the time of consent.
Eastern Cooperative Oncology Group (ECOG) of 0-2.
The subject must have histologically or cytologically confirmed epithelial ovarian,peritoneal or fallopian tube cancer and must have a histological diagnosis of ahigh-grade serous histology based on local histopathological findings.
Subject must have recurrent platinum-resistant or platinum-refractory diseasedefined as: A disease that has progressed by imagining while receiving platinum ORDisease that has recurred within 6 months of the last receipt of platinum-basedchemotherapy. Rising CA-125 only is not considered as platinum-resistant orrefractory disease.
Having received at least 2 prior regimens (including front-line therapy).
Exclusion
Exclusion Criteria:
Subjects with a prior or concurrent malignancy whose natural history or treatmenthas the potential to interfere with the safety or efficacy assessment of theinvestigational regimen are eligible for this trial.
The subject is not willing and not able to comply with study procedures based on thejudgment of the investigator or protocol designee.
The subject is not willing to undergo a biopsy prior to treatment, after infusion,and at the time of disease progression ), and the tumor is determined to be safe bythe treating investigator for biopsy collection.
Study Design
Study Description
Connect with a study center
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
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